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Precision BioSciences Advances Potential Cure for Chronic Hepatitis B with Phase 1 Clinical Trial Applications for PBGENE-HBV

NextEdge Admin

02 Oct 2024

2 min 22 sec

Precision BioSciences, a gene editing company using its proprietary ARCUS® platform, has submitted Clinical Trial Applications (CTA) to begin a Phase 1 study of PBGENE-HBV, an in vivo gene editing therapy designed to potentially cure chronic hepatitis B virus (HBV). PBGENE-HBV targets the elimination of covalently closed circular DNA (cccDNA), the key source of HBV replication, while inactivating integrated HBV DNA in liver cells.

Michael Amoroso, CEO of Precision BioSciences, highlighted the significance of this milestone in addressing HBV, a global health concern affecting an estimated 300 million people. Backed by non-human primate (NHP) safety and efficacy studies, the company is moving forward with regulatory submissions in multiple markets. Precision has also enhanced its clinical team and established a hepatitis scientific advisory board to guide the global Phase 1 trial.

Dr. Murray Abramson, Senior Vice President and Head of Clinical Development, emphasized the limitations of current treatments, which offer only a 1-3% chance of a functional cure. PBGENE-HBV aims to improve these odds by directly eliminating cccDNA, the root source of viral replication. The Phase 1 study is expected to start soon, with data anticipated in 2025. Precision will provide further details about the program’s safety and execution plans in November, ahead of the American Association for the Study of Liver Diseases (AASLD) Annual Meeting.

Precision remains on track to submit additional regulatory applications as part of its global Phase 1 strategy for PBGENE-HBV, with updates to follow.